Statement of Principles concerning gastric ulcer and gastric erosion (Balance of Probabilities) (No. 52 of 2024)

The central concept is the condition itself: "gastric ulcer and gastric erosion". The definition in subsection 7(2) is critical. It means a non-malignant disruption in the mucosal surface of the stomach, including ulcers or erosions due to gastric foreign bodies. The explanatory note clarifies that a gastric erosion is above the lamina propria, while a gastric ulcer extends past the lamina propria through the muscularis mucosa into the submucosa. This anatomical distinction matters for clinical diagnosis but the SoP treats both together. Exclusions are acute haemorrhagic gastritis and stomach perforations from external trauma (stabbing, blast, gunshot). The condition attracts ICD-10-AM code K25, but the SoP's own meaning governs its application, not the code.

The factor framework is the core mechanism. Section 9 lists 22 factors, labelled (1) through (22). Each factor has specific temporal or dosage requirements. For example, factor (1) requires Helicobacter pylori infection of the stomach at the time of clinical onset or clinical worsening. Factor (11) requires smoking at least 10 cigarettes per day (or equivalent) for at least 1 year within the 1.5 years before clinical onset or worsening. Factor (12) requires non-topical NSAID or aspirin use at least every other day for a continuous period of at least 14 days within the 3 months before onset or worsening. Many factors distinguish between "clinical onset" and "clinical worsening". Section 10(2) limits the clinical worsening aspects to situations where the condition was suffered or contracted before or during (but did not arise out of) the person's relevant service, and only to material contribution or aggravation.

The concept of "relevant service" is defined in the Schedule 1 dictionary. It means eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. Note that operational service and hazardous service are excluded from this SoP because they attract a different standard of proof (reasonable hypothesis) under other provisions. This SoP is specifically for the balance of probabilities standard.

The dictionary also defines key terms: "antineoplastic agent" means alkylating agents, antimetabolites, antineoplastic antibodies, or kinase inhibitors. "Critical illness or injury" includes mechanical ventilation or ICU admission, acute renal tubular necrosis, ARDS, severe burns, DIC, multiple organ failure, or septicaemia. "Systemic mastocytosis" means mast cell hyperplasia detected in bone marrow, skin, GI mucosa, liver or spleen. "Terminal event" includes pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. These definitions are essential because they are incorporated into the factors.

Section 11 allows cross-referencing: if a factor refers to an injury or disease for which another SoP has been determined under subsection 196B(3), then the factors in that other SoP apply. For example, factor (20) refers to Crohn disease; if a person claims Crohn disease as the factor, that condition itself must satisfy its own SoP. This prevents circularity and ensures consistency.

The primary affected persons are veterans and members of the Forces who have rendered relevant service as defined in the dictionary: eligible war service (non-operational), defence service (non-hazardous), and peacetime service under the MRCA. This includes those who served in the Australian Defence Force during peacetime, as well as veterans who served in conflicts but whose service is classified as eligible war service rather than operational service. The instrument directly applies to their claims for compensation for gastric ulcer or gastric erosion, or for death from those conditions.

The SoP also affects the Repatriation Commission and the Department of Veterans' Affairs, who must assess claims according to its terms. The Repatriation Medical Authority is the body that determines the SoP, and its decision is binding on the Commission. Medical practitioners who provide evidence in support of claims must understand the factor requirements to ensure their reports address the correct timing, dosage, and diagnostic criteria. Legal practitioners and advocates representing veterans must navigate the factor list and the cross-referencing provisions.

Because the SoP operates on a balance of probabilities standard (as opposed to the reasonable hypothesis standard for operational service), it imposes a higher evidentiary burden on claimants. They must prove at least one factor exists on the balance of probabilities. This affects the likelihood of success for claims. Claimants with conditions arising from service that is not operational or hazardous are the direct target.

Indirectly, the instrument affects taxpayers who fund the veterans' compensation system. The factor list determines eligibility and therefore expenditure. A broader set of factors (e.g., including many drugs, infections, and surgical procedures) increases the potential pool of successful claims. Conversely, the strict temporal requirements and exclusions limit claims. The instrument also affects the medical community by providing a standard for attributing gastric conditions to service, which may influence clinical practice in veterans' health.

Finally, the SoP affects other stakeholders such as the Independent Hospital Pricing Authority (through the reference to ICD-10-AM) and any researchers studying the epidemiology of gastric conditions in veteran populations. The instrument is a legislative tool that shapes the administrative law of veterans' compensation.

Claimants have the right to have their claim assessed under the SoP, and if they can establish at least one factor that is related to their relevant service, the condition is deemed to be connected with service on the balance of probabilities. This is a statutory right created by the VEA and MRCA, operationalised by the SoP. The Repatriation Commission has the duty to apply the SoP to each claim. It cannot refuse a claim solely because the condition is not listed in the SoP if a factor is satisfied, but the SoP is the exclusive pathway for establishing connection.

The RMA has the duty to determine SoPs based on "sound medical-scientific evidence" (section 8). The authority states that it is of the view that the condition can be related to relevant service. This is a legislative finding that binds the Commission. The instrument does not give claimants any new procedural rights; rather, it defines the substantive criteria.

The right to rely on cross-referenced SoPs is important. If a factor such as "having cirrhosis of the liver" (factor 18) is present, the claimant must also satisfy the SoP for cirrhosis if one exists (section 11). That imposes a secondary duty to prove that condition is service-related. The claimant has the right to use the factors in the cirrhosis SoP to establish that factor.

The duty of proof lies with the claimant to produce evidence that a factor exists at the relevant time. The SoP specifies the temporal window: for example, critical illness within 14 days before clinical onset, or smoking within 1.5 years. The claimant must demonstrate compliance with these windows. The Commission has a duty to assess the evidence fairly, but the instrument does not create a right to any particular procedure.

For clinical worsening, the instrument imposes a limitation: the worsening factors apply only where the condition was suffered or contracted before or during service but did not arise out of service (section 10(2)). The worsening must be a material contribution or aggravation. This limits the right to claim aggravation to those who already had gastric ulcer or erosion before service.

There is no right to compensation if no factor is established. The SoP is exhaustive; no other basis for connection is available under the balance of probabilities standard. Claimants who fail to satisfy a factor may still succeed under the reasonable hypothesis standard for operational service, but that is outside this instrument.

This instrument does not itself create any penalties. It is a legislative determination that sets eligibility criteria, not a prohibitory or regulatory code. Enforcement is through the claims process under the VEA and MRCA. If a claimant fraudulently asserts a factor that does not exist, they may be subject to general criminal provisions for making false statements or obtaining a financial advantage, but that is covered by other laws, not this SoP.

The practical "penalty" for failing to comply with the SoP is denial of the claim. The Commission will reject the claim if no factor is established or if the factor is not related to service. There is no fine or sanction against the claimant for a failed claim.

However, the instrument imposes a serious legal consequence: it defines the standard of proof (balance of probabilities) and the factors that must be proven. Medical practitioners giving evidence must ensure their reports comply with the instrument's requirements. If a medical report is found to be incorrect or incomplete, it could undermine the claim, and in extreme cases the practitioner could face professional misconduct proceedings, but that is not enforcement under this SoP.

The Repatriation Medical Authority itself is subject to judicial review of its decisions to make SoPs, but that is a separate process. The instrument includes no enforcement mechanisms, only the foundational rules for decision-making.

The SoP operates under the Veterans' Entitlements Act 1986, specifically subsection 196B(3). It interacts with the standard of proof provisions in sections 120B of the VEA and 339 of the MRCA. Those sections provide that a claim is to be determined by applying any relevant SoP, and that the SoP binds the decision-maker. This instrument is one such SoP.

Section 11 of the instrument explicitly integrates other SoPs. If a factor refers to an injury or disease for which an SoP has been made under subsection 196B(3), then the factors in that SoP apply. This creates a network of interlocking instruments. For example, if factor (1) (Helicobacter pylori infection) is relied upon, that infection itself is a disease, and there is likely an SoP for Helicobacter pylori infection (or infection generally). The claimant would need to satisfy both SoPs. This prevents fragmentation.

The SoP repeals the earlier Statement of Principles concerning gastric ulcer and duodenal ulcer (No. 62 of 2015). That earlier SoP covered both conditions together. The separation means that duodenal ulcer now likely has its own SoP (not provided here). Practitioners must ensure they use the correct instrument. The repeal also means that claims lodged after 23 July 2024 are governed by this SoP, not the old one.

The SoP references the ICD-10-AM classification (Tenth Edition) for coding purposes, but the condition's meaning is not limited by that code. The instrument's definition takes precedence. This avoids rigidity if the ICD coding changes.

The instrument does not override the VEA or MRCA themselves; it operates within their framework. The definition of "relevant service" in the dictionary excludes operational service and hazardous service. For those types of service, different SoPs (made under subsection 196B(2) for reasonable hypothesis) would apply. This SoP is specifically for the balance of probabilities standard under subsection 196B(3). Practitioners must check which type of service the claimant rendered.

Finally, the SoP interacts with the general law of evidence and administrative law. Claimants can seek review of decisions in the Veterans' Review Board and the Administrative Appeals Tribunal, applying the SoP. The courts can consider whether the RMA acted within power, but the instrument itself is a legislative instrument subject to disallowance by Parliament.

This instrument, No. 52 of 2024, repeals the Statement of Principles concerning gastric ulcer and duodenal ulcer No. 62 of 2015 (Federal Register of Legislation No. F2015L00658). The earlier SoP was made under both subsections 196B(3) and (8) of the VEA, meaning it covered both the balance of probabilities and reasonable hypothesis standards. The new SoP is made only under subsection 196B(3) and thus applies solely to the balance of probabilities standard. This suggests that a separate SoP for reasonable hypothesis (for operational service) may be issued separately, or the RMA determined that only the balance of probabilities SoP needed updating.

The repeal removes the combined gastric and duodenal ulcer instrument. The new SoP limits its scope to gastric ulcer and gastric erosion, leaving duodenal ulcer to be covered by a different instrument (likely No. 51 of 2024 or similar, not provided). This reflects a more precise approach to condition definitions.

The instrument commenced on 23 July 2024, three days after date of signature (21 June 2024). It does not contain transitional provisions; it applies to all claims made on or after that date and to claims under section 120B of the VEA or section 339 of the MRCA that are not yet finally determined.

No earlier SoP for gastric ulcer alone existed (the 2015 one covered both). The RMA has not indicated why the separation occurred, but the source provides no amendment history beyond the repeal. The instrument is a standalone replacement.

The source text does not reference any litigation history. No cases are named. In the broader context, Statements of Principles are frequently litigated in the Administrative Appeals Tribunal and the Federal Court, often on grounds of the RMA failing to consider sound medical-scientific evidence or misinterpreting the statutory test. However, specific litigation involving this particular instrument cannot be discussed because it commenced only on 23 July 2024, and the source is silent on any prior challenges to the predecessor SoP.

Given the strict instruction to only name cases the source names, and the source names none, this section must state that no litigation history is provided in the instrument. The analyst can note that the instrument is authoritative and has not been judicially considered in the material provided. The repeal of the 2015 SoP may have been prompted by litigation or by updated medical evidence, but the source gives no indication.

Therefore, this section must be brief and grounded: the instrument contains no reference to any court or tribunal decisions, and no litigation is recorded in the text. The user is advised to check the Federal Register of Legislation for any court decisions citing this instrument after its commencement.

Several provisions in this SoP create traps for the unwary. First, factor (22) is extraordinarily broad: "inability to obtain appropriate clinical management for gastric ulcer or gastric erosion before clinical worsening." This factor applies at the time of clinical worsening, and it does not define "inability". Could a veteran claim they could not obtain appropriate management because the treating doctor refused a particular drug, or because of wait times? The instrument does not clarify, leaving room for subjective interpretation. The factor exists only for clinical worsening, not onset.

Second, factor (19) applies only to bleeding of a gastric ulcer, not to gastric erosion. The note explicitly says bleeding of a gastric ulcer is considered a clinical worsening. So a veteran with an erosion that bleeds cannot use this factor. Also, factor (19) requires either alcohol use disorder or drinking at least 4 standard drinks per day for at least 6 months at the time of bleeding. The alcohol consumption is calculated using the Australian Standard of 10 grams per drink. This is a higher threshold than many other alcohol-related SoPs.

Third, the temporal requirements are strict and easily missed. For example, factor (11) requires smoking at least 10 cigarettes per day for at least 1 year within the 1.5 years before clinical onset or worsening. The smoking must be continuous for a year, but the 1.5-year window is backward from the event. If a veteran quit smoking 2 years before onset, they cannot use this factor. Similarly, factor (12) requires NSAID use at least every other day for a continuous period of at least 14 days within 3 months before onset. A break of more than one day resets the period.

Fourth, factor (3) requires critical illness or injury within 14 days before clinical onset or worsening. The definition of "critical illness or injury" includes "any physical injury or illness requiring mechanical ventilation support or admission to an intensive care unit." That is very broad; a one-day ICU stay qualifies. But the timing window is only 14 days, so the stress of ICU must occur just before the gastric condition manifests.

Fifth, factor (17) lists drugs that apply specifically to clinical worsening, while factor (16) lists drugs for clinical onset. The two lists are different. For example, anticoagulants appear only in factor (17) (worsening), not in factor (16) (onset). If a veteran develops a gastric ulcer while on warfarin, they cannot rely on that factor for onset; they would need a different factor. Practitioners must match the drug list to the correct event.

Sixth, the cross-referencing trap (section 11): if a factor refers to another disease (e.g., Crohn disease, cirrhosis, Helicobacter pylori infection), the claimant must also satisfy the SoP for that disease. This adds complexity. A veteran with cirrhosis must prove that cirrhosis is related to service via its own SoP before cirrhosis can be used as a factor for gastric ulcer.

Seventh, the dictionary definition of "relevant service" excludes operational service and hazardous service. Many veterans may think their service is covered, but if they served in a combat zone, this SoP likely does not apply to them; they would need a reasonable hypothesis SoP. The instrument is titled "Balance of Probabilities" to make that clear.

Eighth, the definition of "gastric ulcer and gastric erosion" excludes acute haemorrhagic gastritis. If a veteran presents with gastric bleeding diagnosed as acute haemorrhagic gastritis, this SoP does not apply; they would need a different SoP for gastritis.

Ninth, factor (14) requires a solid organ or bone marrow transplant before clinical onset or worsening. The timing is "before" the event; there is no required period. But if the transplant is many years before, it may still qualify. However, the factor must be related to service - the transplant itself must be service-related, which may be difficult for peacetime service.

Tenth, factor (21) includes "systemic mastocytosis" which is defined in the dictionary as hyperplasia detected in bone marrow, skin, GI mucosa, liver or spleen. But the condition must be at the time of onset or worsening. Diagnosis may be rare; claimants must provide pathological evidence.

For a claimant to successfully connect gastric ulcer or gastric erosion to relevant service under this SoP, they must demonstrate on the balance of probabilities that at least one of the 22 factors existed at the required time, and that the factor itself is related to service. The following steps outline compliance.

First, obtain a definitive diagnosis of gastric ulcer or gastric erosion from a gastroenterologist or pathologist, ensuring it meets the definition in subsection 7(2). Exclude acute haemorrhagic gastritis and external trauma perforations. The diagnosis must distinguish between erosion and ulcer.

Second, identify the date of clinical onset and, if applicable, clinical worsening. Clinical onset is when symptoms first appear or the condition is first detected. Clinical worsening is a material increase in severity after onset. The factors often require timing relative to these events. The claimant should gather medical records to pinpoint these dates.

Third, review the factor list systematically. For each factor, consider the temporal and dosage requirements. For example:

• For infection (factors 1 and 2): obtain proof of Helicobacter pylori infection (e.g., breath test, biopsy, serology) at the time of onset. For other organisms, specific diagnostic tests.
• For critical illness (factor 3): document admission to ICU or mechanical ventilation within 14 days before onset. Hospital records are essential.
• For smoking (factor 11): collect evidence of smoking at least 10 cigarettes per day for at least one year within the 1.5 years before onset. Self-reporting may be insufficient; GP records, service medical records, or pharmacy records help.
• For NSAID/aspirin (factor 12): prove use at least every other day for 14 consecutive days within 3 months before onset. Prescription records, hospital charts, or patient diaries.
• For drugs listed in factors 15, 16, 17: ensure the specific drug and timing matches. For example, factor 16 requires treatment for at least 2 weeks within 3 months before onset. Factor 17 requires the same window for worsening but with different drugs.
• For alcohol (factor 19): only applies to bleeding of a gastric ulcer. Prove consumption of at least 4 standard drinks per day for at least 6 months at the time of bleeding. Use AUDIT or similar.
• For inability to obtain management (factor 22): document that appropriate clinical management was not available or not provided, and that this caused clinical worsening. This is the most open-ended factor and requires careful narrative.

Fourth, ensure the factor is related to relevant service. For example, if relying on Helicobacter pylori infection, the infection must have been acquired during or as a result of service. The RMA expects that the factor arises out of service. If the factor is a disease like cirrhosis, the cirrhosis itself must be connected to service via its own SoP (section 11). Practitioners should check the relevant SoP for each secondary condition.

Fifth, for clinical worsening, confirm that the condition was suffered or contracted before or during service but did not arise out of service (section 10(2)). Then identify a factor that caused material contribution or aggravation. The worsening factors in section 9 apply only to this context.

Sixth, compile all evidence into a claim submission with cross-references to the specific factor number. The Repatriation Commission will assess the claim. If the claim is denied, review can be sought. Practitioners should be aware of the strict evidentiary standard: balance of probabilities, meaning more likely than not.

Seventh, monitor any subsequent amendments to the SoP. The instrument may be updated as medical science evolves. This SoP is current from 23 July 2024.